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NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04841070
Acronym
NEUROPHON
Enrollment
55
Registered
2021-04-12
Start date
2021-07-25
Completion date
2021-10-29
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Pulmonary Hypertension of the Newborn

Brief summary

Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology. In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period

Interventions

OTHERAges & Stages Questionnaires®, Third Edition (ASQ3)

Investigators will propose to parents of children hospitalized for the treatment of persistent pulmonary hypertension of the newborn a hetero-evaluation via the validated ASQ questionnaire to analyze neuro-psychomotor development.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

* All parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal PAH in paediatric resuscitation

Exclusion criteria

* Holders of parental authority who cannot answer the questionnaire because they do not speak French. * Opposition of one of the two holders of parental authority * Minor parental authority holders * Holders of parental authority under safeguarding of justice, guardianship or guardianship * Newborns with neonatal PAH with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease * Newborns with neonatal PAH not treated with nitrogen monoxide

Design outcomes

Primary

MeasureTime frameDescription
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.Between one and 5 years after hospitalization in resuscitation.Parents will complete ASQ3. The investigators will consider neuro-psychomotor developmental disorders in children with pathological ASQ questionnaire on at least 2 items.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026